Gufunga amasahani bigira uruhare runini mugukosora kuvunika no kubaka amagufwa. Mu myaka icumi ishize, Ubushinwa bukora ibyuma bifunga amasahani byahinduye ibintu bidasanzwe - kuva mu kwigana kugera ku guhanga udushya, kuva mu mashini zisanzwe kugeza ku buhanga bwuzuye. Muri iki gihe, inganda z’Abashinwa zigaragara nk’abatanga isoko rikomeye ku isi bazwiho guhanga udushya, gukoresha neza ibiciro, no kubahiriza ubuziranenge mpuzamahanga.
Kuzamura Ikoranabuhanga mu Gufunga Isahani
Inganda zikora amagufwa mu Bushinwa zasimbutse cyane mu ikoranabuhanga mu nganda. Inganda zigezweho ubu zifata imashini zigezweho za CNC, guhimba neza, hamwe na sisitemu yo gusya byikora, bigafasha kugenzura neza guhuza umwobo, guhuza imiyoboro, hamwe na anatomique.
Ibikoresho byo mu Busuwisi bikozwe neza cyane, byakozwe mbere yo gukora amasaha, ubu bikoreshwa cyane mu gukora plaque orthopedic. Ibi byerekana micron-urwego rwukuri, isura nziza, hamwe nibisubirwamo byiza - nibyingenzi kugirango habeho ituze no kuramba bya sisitemu yo gufunga.
Guhanga ibintu ni ikindi gice cyingenzi. Ababikora bahindukiriye imiti yo mu rwego rwo kwa titanium hamwe na modulus nkeya idafite ibyuma bidafite ibyuma, bitanga imbaraga zumukanishi, biocompatibilité, hamwe no kurwanya umunaniro. Byongeye kandi, kuvura hejuru nka anodizing na passivation biteza imbere kurwanya ruswa no guhuza ingirangingo.
Inganda zAbashinwa nazo zateye imbere muburyo bwihariye bwa anatomical. Haba T-shusho, L-shusho, cyangwa isahani yuzuye amagufwa, ibicuruzwa birashobora guhuzwa nu turere twihariye two kubaga cyangwa ibisabwa kwa muganga. Uku guhuza ubuhanga bwubuhanga hamwe nuburyo bworoshye bwo gukora butuma ibyapa bifunga abashinwa byujuje ubuziranenge mpuzamahanga kandi bigahiganwa neza kumasoko yisi.
Impamyabumenyi mpuzamahanga: CE na FDA
Kubicuruzwa byamagufwa byinjira kumasoko yisi yose, ibyemezo byubuyobozi ni ngombwa. Inganda z’Abashinwa zarushijeho kubona ibyemezo bya CE, FDA, na ISO 13485, byerekana ko byubahirizwa n’ubuziranenge mpuzamahanga n’umutekano.
Icyemezo cya CE (EU MDR)
Mu Mabwiriza y’ubuvuzi bw’ibihugu by’i Burayi (MDR 2017/745), ibyapa bifunga bigomba gutsinda isuzuma rikomeye ryerekana ibishushanyo mbonera, ibikoresho, imicungire y’ibyago, n’isuzuma ry’amavuriro. Abashoramari benshi b'Abashinwa bujuje neza ibyo basabwa, bituma ibicuruzwa byabo byemerwa kugurishwa mu bihugu by’Uburayi ndetse n’andi masoko azwi na CE.
FDA 510 (k) Kwemeza (Amerika)
Amasosiyete menshi yo mu Bushinwa yageze kuri FDA 510 (k), yerekana uburinganire bukomeye bwibikoresho bimaze kugaragara ku isoko ry’Amerika. Ibi byemezo byerekana gukura kwa tekinike hamwe nubushobozi bwinyandiko zabakora orthopedic yubushinwa.
Ku baguzi ku isi, guhitamo abaguzi bafite ibyemezo bya CE na FDA bitanga icyizere cyo kugenzura, gukurikiranwa, no kubona isoko.
Ikiguzi-Imikorere Inyungu Zabakora Ubushinwa
Imwe mumpamvu zikomeye abaguzi bahitamo gufunga amasahani ava mubushinwa ni igipimo kidasanzwe cyibikorwa.
Igiciro cyo kubyaza umusaruro muke, gisobanutse neza: Bitewe no kwikora, umurimo unoze, hamwe nuruhererekane rwo gutanga amasoko, amasahani yo gufunga yakozwe nabashinwa arashobora kugura 30-50% ugereranije nibicuruzwa by’iburayi cyangwa Amerika byagereranywa, bitabangamiye ubuziranenge.
Ubushobozi bunini bwo gutanga umusaruro: Ibikoresho binini byemerera kugenzura ubuziranenge hamwe nigihe gito cyo kuyobora. Inganda nyinshi zirashobora kuzuza ibyiciro bito bya OEM hamwe nibicuruzwa byinshi kubitaro cyangwa kubitanga.
Guhindura ibintu byihariye: Abashinwa batanga ibicuruzwa bizwiho ubushobozi bwo gukora ibishushanyo byabigenewe bifite umubare muto muto wo gutumiza (MOQs), bitanga ihinduka ryinshi kubagabuzi cyangwa amavuriro yihariye.
Uburambe bukomeye bwo kohereza ibicuruzwa hanze: Hamwe nibicuruzwa byoherejwe mubihugu birenga 50, amasosiyete y abashinwa azi neza ibikoresho mpuzamahanga, ibikoresho, hamwe na gasutamo, bituma habaho ubufatanye bwiza nabafatanyabikorwa b’amahanga.
Kubera iyo mpamvu, amatsinda yo gutanga amasoko ku isi asanga ibyapa bifunga abashinwa ari uburinganire bwubwenge bwiza, imikorere, kandi bihendutse - cyane cyane kubisoko bisaba kwizerwa no gukora neza.
Kongera Kwakirwa nabaganga bo hanze
Imyaka icumi ishize, bamwe mubaganga babaga batinyutse gukoresha ibishinwa bikozwe mubushinwa kubera impungenge zokwizerwa igihe kirekire cyangwa icyuho cyimpamyabumenyi. Iyo myumvire yarahindutse cyane.
1.Imikorere myiza yubuvuzi: Hamwe nibikoresho byazamuwe hamwe no gutunganya neza, imbaraga za mashini hamwe na anatomique ihuza amasahani yo gufunga abashinwa ubu bahanganye nibirango byamenyekanye muburengerazuba.
2.Ibitekerezo byiza byatanzwe n’abakoresha isi yose: Abacuruzi mpuzamahanga benshi bavuga ko nyuma yo guhindukira ku baguzi b’abashinwa, ibitekerezo by’ibitaro n’abaganga babaga bishimishije cyane, nta tandukaniro rikomeye ugereranije n’ibikoresho by’i Burayi.
3.Gufatanya na R&D hamwe n'inkunga ya tekiniki: Abakora mubushinwa barushijeho kugira uruhare mugutezimbere hamwe nabafatanyabikorwa b’amahanga, batanga umurongo ngenderwaho wa tekinike yo kubaga, amahugurwa y'ibicuruzwa, hamwe n'inkunga ku rubuga - kubaka ikizere gikomeye n'imibanire y'igihe kirekire.
4.Kumenyekana binyuze mu mpamyabumenyi no mu nama: Kwitabira imurikagurisha ry’ubuvuzi ku isi nka MEDICA na AAOS ryarushijeho kwiyongera no kwizerwa mu bakora umwuga w'amagufwa ku isi.
Mugihe urwego rwogutanga amasoko atandukanye, "Made in China" ibyapa byo gufunga ntibikiboneka nkibindi bisobanuro byo hasi ariko nkibisubizo byizewe, byemejwe, kandi byateye imbere mubuhanga byizewe nabaganga babaga muri Aziya, Uburayi, na Amerika.
Imbaraga zacu nka aGufunga Isahani ikora mubushinwa
Nkumunyamwuga wo gufunga ibyapa nabatanga isoko, isosiyete yacu yubatse izina rikomeye rishingiye ku ikoranabuhanga, neza, no kwizerwa.
Ubuhanga bwashyizweho - Hamwe nuburambe bwimyaka munganda zikora amagufwa, twateje imbere R&D nubushobozi bwubuhanga bukomeza gutwara udushya.
Ibikoresho byo mu rwego rw’Ubusuwisi - Ibikoresho byacu bitanga umusaruro bikoresha sisitemu yo gutunganya ibicuruzwa byakozwe mu Busuwisi, byakozwe mbere na mbere mu gukora amasaha neza, byemeza neza ko bidashoboka kandi bihamye muri buri sahani dukora.
Guhindura no guhinduka - Dutanga intera nini yubwoko bwa plaque - igororotse, T-shusho, L-shusho, hamwe na plaque anatomique - kandi dushyigikira igishushanyo cyihariye gishingiye kubisabwa byubuvuzi cyangwa akarere.
Umusaruro munini - Dukorana numurongo wumusaruro uhuriweho, kuva gutunganya ibikoresho fatizo kugeza kugenzura ubuziranenge no gupakira, dushyigikira ibicuruzwa binini hamwe nigihe gito cyo kuyobora.
Sisitemu yubuziranenge yuzuye - Inganda zacu zikurikiza amahame mpuzamahanga akomeye hamwe na sisitemu yo gucunga ubuziranenge (ISO 13485, CE, kubahiriza FDA), bigatuma isoko ryisi ryiteguye.
Serivisi ishingiye kubakiriya - Kurenga gukora, dutanga inkunga ya tekiniki, inyandiko y'ibicuruzwa, hamwe no guhuza ibikoresho kugirango dufashe abagabuzi n'ibitaro kumenyekanisha ibicuruzwa byacu neza.
Umwanzuro
Inganda zikora amasahani mu Bushinwa ziragenda zihuta zigana ku buryo bunoze, bufite ireme, ndetse n’icyizere mpuzamahanga. Hamwe nikoranabuhanga ryateye imbere, ibyemezo bya CE / FDA, hamwe ninyungu zikomeye, abatanga ibicuruzwa mubushinwa barimo kuvugurura imiterere yimikorere yisi yose.
Nkumwe mubakora ibicuruzwa bifunga ibyapa mubushinwa, twishimiye guhuza urwego rwubusuwisi neza, ubushobozi bwo gushushanya ibicuruzwa, hamwe nubushobozi buke bwo gutanga umusaruro kugirango tubone ibisubizo byizewe kubanyamwuga b'amagufwa ku isi.
Igihe cyo kohereza: Ugushyingo-04-2025